A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Recruiting
N/AInterventional Study
Hematoma BrainLarge Basal Ganglia Hemorrhage
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
198 (estimated)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Other
Who this trial is looking for
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This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years at randomization;
2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
3. Hematoma volume ≥30 mL prior to randomization;
4. Glasgow Coma Scale (GCS) score ≥ 5;
5. Available for surgery within 72 hours after onset;
6. Modified Rank…
Inclusion Criteria:
1. Age ≥18 years at randomization;
2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
3. Hematoma volume ≥30 mL prior to randomization;
4. Glasgow Coma Scale (GCS) score ≥ 5;
5. Available for surgery within 72 hours after onset;
6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
Exclusion Criteria:
1. Hematoma involving the thalamus (volume \>5 mL or diameter \>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
2. Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;
3. Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
4. Any irreversible coagulation disorder or known coagulopathy; platelet count \<100,000; INR \>1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
5. Current or probable pregnancy;
6. Patients with concurrent severe illness likely to influence outcome assessment;
7. Difficulty in follow-up or poor compliance due to any cause.
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